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Self Propelled Robotic Wheel (SPRW)

by Datatran, Inc. 510(k)

Active United States

510(k) K950025

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950025 Date3 Sep 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Self Propelled Robotic Wheel (SPRW) is a powered wheelchair device classified under regulation number 890.3860 and product code ITI. It is substantially equivalent to a legally marketed device and falls under the medical specialty of Physical Medicine.

The device is supplied as a Class II medical device with FDA 510(k) clearance under number K950025, granted on September 3, 1996, following a traditional review. It is manufactured by Datatran, Inc. located in East Haven, Connecticut, and is intended for use in accordance with its cleared indications within the Physical Medicine specialty.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Self Propelled Robotic Wheel (SPRW) used for?

    The SPRW is a powered wheelchair device intended for use in the Physical Medicine specialty, as indicated by its FDA 510(k) clearance and product code ITI under regulation 890.3860.

  • How is the SPRW supplied and what is its regulatory status?

    The SPRW is supplied as a Class II medical device with FDA 510(k) clearance under number K950025, granted on September 3, 1996, following a traditional review process, and is manufactured by Datatran, Inc. in East Haven, Connecticut.

  • Is the SPRW a single-use or reusable device?

    The SPRW is a powered wheelchair designed for repeated use, as it is a Class II medical device intended for ongoing patient mobility support in Physical Medicine settings, not a disposable or single-use product.